Description
We are currently looking for a Diagnostics Lead to join our Innovative Devices Function within the Innovation & Compliance Group.
This is a full-time opportunity, on a permanent basis. The role will be based in 10 South Colonnade, Canary Wharf London, E14 4PU.
Government departments and agencies are working towards implementing a minimum 60% attendance in office sites.
We are currently implementing a flexible, hybrid way of working, with a minimum of 8 days per month working on site to enable the collaboration and contact with partners and stakeholders needed to deliver MHRA business. Attendance on site is driven by business needs so depending on the nature of the role, this can flex up to 12 days a month, with the remainder of time worked either remotely or in the office. Some roles will need to be on site more regularly. Remote working is potentially available for some specific roles.
The Diagnostics Lead will contribute and support senior colleagues on the development and implementation of IVD Regulations as part of the wider MedTech Regulatory Reform.
The successful candidate will:
Regulations and policy:
- Contribute to the development and implementation of IVD Regulations as part of the broader MedTech Regulatory Reform programme, focusing on access to safer and more effective IVD devices.
- Lead the scientific and technical capability of the team to inform regulatory decision making, as well as providing input into guidance and standards development.
- Lead the delivery of aspects of the new IVD regulatory regime with support from senior colleagues.
- Support senior colleagues on the delivery of new Diagnostics legislation, including policy development, ministerial submissions, parliamentary debates, impact analysis and communication plans.
Communication and partnership:
- Lead frequent engagement with stakeholders, internally and externally, on all matters affecting regulatory policy and strategy development for Diagnostics.
- Contribute to maintaining effective communication across the agency, as well as responding to enquiries from external stakeholders.
- Support the establishment of partnerships with key external stakeholders.
- Coordinate the effective liaison with key stakeholders on all issues affecting regulatory policy.
Safety and surveillance:
- In collaboration with the Safety and Surveillance team, contribute to establishing effective mechanisms for collecting and analysing safety signals of IVD devices on the UK market.
Process improvement:
- Organise the continuous improvement in ways of working within the team.
The job description is not intended to be exhaustive, and it is likely that responsibilities and outcomes may be altered from time to time in the light of changing circumstances and after consultation with the postholder.
Person specification:
Essential Criteria:
- Previous experience in IVD or a similar regulatory area, for example medical devices, including in a clinical, commercial, academic or policy setting.
Desirable:
- Experience of developing, evaluating and/or policy development.
Qualifications:
- Bachelor’s degree of equivalent in a scientific, engineering or medical discipline.
Behaviours:
- Seeing the Big Picture
- Changing and Improving
- Communicating and Influencing
- Delivering at Pace
Technical skills:
- Bachelor’s degree of equivalent in a scientific, engineering or medical discipline (Essential)
- A Masters, PhD or equivalent in a scientific, engineering or medical discipline (Desirable).
- Knowledge of current UK MDR and EU IVDR, understanding of the methodological approaches used to demonstrate IVD performance (Desirable)
Benefits:
- Salary of £47,776
- Medicines and Healthcare Products Regulatory Agency contributes £13,840 towards you being a member of the Civil Service Defined Benefit Pension scheme.
- Annual Leave: 25 days annual leave on entry, rising by one day for each completed year of service to a maximum of 30 days and pro-rata for part-time staff.
- Privilege Leave: 1 day
- Hours of Work: 37 hours (net) per week for full time staff in all geographical locations.
- Occupational Sick Pay (OSP): One month full pay/one month half pay on entry.
- Mobility: Mobility clause in contracts allowing staff to be mobile across the Civil Service.
- Civil Service Pension Scheme.
- Flexible working to ensure staff maintain a healthy work-life balance.
- Interest free season ticket loan or bike loan.
- Employee Assistance Services and access to the Civil Service Benevolent Fund.
- Eligibility to join Motoring, Boundless by CSMA.
- Variety of staff and Civil Service clubs.
- On-going learning and development.
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